Omnibond vs Dermabond

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Conditions studied: Osteoarthritis

In brief

This prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (TJA) when two different types of topical skin adhesives are used to close the incision.

Key facts

Study ID

NCT05173519

Run by

Center for Innovation and Research Organization

People needed

310

Starts

2022-10-25

Expected to finish

2025-02-01

Last updated by the study team

2024-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient ≥18 years old
• Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
• Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty
• Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
• Subjects deemed able to understand and comply with study visit schedule and procedures

You may not qualify if…

• Local skin conditions such as dermatitis, eczema, psoriasis that, in the opinion of the investigator, will make it difficult to assess wound complications or local skin reactions following surgery
• Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
• Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene
• Subjects who have participated in this trial previously and who were withdrawn
• Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing.
• Inability or refusal to provide informed consent or follow study and wound care instructions

Where it is running

• Columbia University — New York, New York, United States
• JIS Orthopaedics — New Albany, Ohio, United States
• Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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